Health TrialsbyHealthPanel

Surfactant Administration by Insure or Thin Catheter

ConditionsRDS of PrematuritySurfactant Deficiency Syndrome NeonatalAnalgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorKarolinska Institutet

About this trial

This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.

Disqualifiers

Infants requiring surfactant as part of delivery room resuscitation are not eligible.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thin catheter technique or standard ET-tube for surfactant administration

    Procedure/Surgery

    Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: INSUREActive comparator 1 intervention
Group B: LISAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oxygenation

Arterial to alveolar ratio (a/A ratio)

Time frame
24 hours post-procedure
2

Mechanical ventilation

Need for intubation and mechanical ventilation (MV)

Time frame
48 hours post-procedure

Secondary outcomes

1

Duration of ventilatory support

Duration of MV (hours), CPAP (days), Oxygen (days)

Time frame
Discharge
2

Complications

Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct

Time frame
Discharge
3

Mortality

Death or composite outcome death/BPD

Time frame
Discharge
4

Length of stay

Number of days in NICU and total in neonatal care, including home care

Time frame
Discharge

Other outcomes

1

Delay time

Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration

Time frame
24 hours
2

Intubation attempts

Number of tries before successful intubation/placement of catheter

Time frame
24 hours
3

PPV

Positive pressure ventilation during the procedure - yes/no/duration (minutes)

Time frame
24 hours
4

Stress and pain

Changes in heart rate, blood pressure and BIIP-scales

Time frame
24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Source ClinicalTrials.gov
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